Validation Engineer, Sterility Assurance

Intuitive; Sunnyvale (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Intuitive Surgical is seeking a Validation Engineer, Sterility Assurance to oversee EO and radiation bioburden programs for single-use devices and accessories. You will interface with R&D, Manufacturing, Quality, and external labs to drive projects to completion and improve processes while meeting regulatory requirements.

The role emphasizes data-driven decision making, strict adherence to validated methods, and collaboration across multiple teams to ensure the safety and efficacy of new and

Qualifications

• Experience managing EO and radiation bioburden testing.
• Ability to coordinate with cross-functional teams and external labs.
• Strong data analysis to ensure safety and efficacy of instruments.
• Familiarity with regulatory quality systems and sterilization standards.

Responsibilities

• Manage routine EO and radiation bioburden testing and coordinate with cross-functional teams, sterilizers, and laboratories to drive projects to completion.
• Support Intuitive’s internal microbiology lab, following validated test methods as required.
• Provide technical support to sterilization release activities.
• Maintain bioburden procedures based on recognized standards.
• Assist with compliance audits for external facilities as required to support quality management system.

Job description

Job Description

Primary Function of the Position

Intuitive Surgical designs and manufactures highly complex systems for use in surgery. These systems employ a combination of reusable and single use surgical instruments and accessories for each surgical procedure. The primary function of the Validation Engineer, Sterility Assurance is to support sterilization processes of existing and newly developed single-use products. This person will act as an interface between internal project teams (e.g. Research and Development, Manufacturing Engineering, Supplier Engineering, Quality Engineering, etc.) and external laboratories and sterilizers.
The successful candidate must excel in a high-energy, high transaction, small and focused team environment, be able to drive to solutions from rough requirements, and have a commitment to high product quality and compliance. The ability to understand project goals and communicate test plans required to achieve those goals is essential. A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting. Supporting this role will be a technical and management team that knows and cares about what you are doing and wants you to succeed.

Essential Job Duties

• Manage routine Ethylene Oxide (EO) and radiation bioburden testing, coordinate with cross-functional teams, sterilizers, and laboratories and drive projects to completion.
• Support Intuitive’s internal microbiology lab, following validated test methods as required.
• Apply technical expertise to the bioburden program (e.g. interpretation of results, investigation of excursions, etc.).
• Support the bioburden program, involving rigorous data analysis with focus on the safety and efficacy of single-use daVinci® surgical instruments and accessories for new products and sustaining projects (e.g. cost reduction, process improvements, etc.).
• Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (sterilizers, suppliers, and laboratories).
• Provide technical support to routine sterilization release activities.
• Maintain Intuitive Surgical bioburden procedures based on recognized standards.
• Implement projects per approved budget and schedule.
• With support from the sterilization team, conduct, review and approve incident investigations. Review corrective actions and develop reliable preventative actions related to sterilization as a result of any nonconformity.
• Assist with compliance audits for external facilities as required to support quality management system.